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Evaluation of the Safety and Effectiveness of ARTIA Reconstructive Tissue Matrix Breast Reconstruction (ADORA) in Adult Participants

NCT06575192

RecruitingPhase 3

Sponsor: AbbVie

Conditions: Breast Reconstruction

Interventions: ARTIA Reconstructive Tissue Matrix

Countries: United States

The purpose of this study is to evaluate the safety and effectiveness of ARTIA in adult participants undergoing immediate, two-stage, implant-based breast reconstruction post-mastectomy.

Eligibility overview

Sex: FEMALE

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* Participants who will undergo unilateral or bilateral mastectomy upon enrollment.
* Participants who are willing and able to undergo immediate prepectoral, implant based, two-stage breast reconstruction with ARTIA.

Exclusion Criteria:

* Has an existing carcinoma of the breast without planned mastectomy or residual gross local tumor of the breast after mastectomy.
* Has any disease which is clinically known to impact wound healing ability, such as uncontrolled diabetes or history of compromised wound healing.

Locations (23)

Los Angeles, California, United States
Orange, California, United States
Palo Alto, California, United States
Torrance, California, United States
Aurora, Colorado, United States
Brandon, Florida, United States
Gainesville, Florida, United States
Chicago, Illinois, United States
Northbrook, Illinois, United States
Baltimore, Maryland, United States
St Louis, Missouri, United States
Las Vegas, Nevada, United States
Newark, New Jersey, United States
Lake Success, New York, United States
New York, New York, United States
Winston-Salem, North Carolina, United States
Columbus, Ohio, United States
Chattanooga, Tennessee, United States
Johnson City, Tennessee, United States
Houston, Texas, United States
Draper, Utah, United States
Charlottesville, Virginia, United States
Vancouver, Washington, United States